A Randomised Controlled Multicenter Trial Evaluating the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Caesarean section rate
研究概览
简要总结
The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia.
Secondary objectives:
To demonstrate that acupuncture can:
- reduce morbidity, fetal mortality and duration of childbirth;
- reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor;
- to evaluate the tolerance.
详细描述
In this trial, pregnant women with at least 37 weeks of amenorrhea will be randomized to traditional chinese acupuncture, sham acupuncture, or usual care only.
9 investigator sites will participate to this trial targeting to enrol 2220 patients in total. 1780 subjects will receive acupuncture treatment, either effective treatment or sham, whereas 400 patients will receive usual care only.
Acupuncture therapy consists in stimulations on specific skin points of the abdominal area, which are specific acupuncture points in traditional chinese medicine for the induction of obstetric labor, according to the professional recommendations of the French Acupuncture and Traditional Chinese Medicine College.
Each patient will have a 5-week follow-up in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Signed informed consent
- •Woman carrying one foetus only
- •at 37 weeks (+/- 2 days) of amenorrhea
- •Without contraindication to vaginal delivery
排除标准
- •Prior history of caesarean section
- •Non-cephalic presentation
- •Fetal macrosomia
- •Multiple pregnancy
- •Chronic fetal hypoxia
- •Placenta praevia
- •Risk of neonatal contamination
结局指标
主要结局
Caesarean section rate
时间窗: up to 37 weeks
Rate of caesarean section for cervical dystocia in full-time pregnancies
次要结局
未报告次要终点